The purpose of this study is to compare the effects of pomegranate polyphenol pills (POM-X) and a placebo (sugar pill) on prostatic oxidative stress. The placebo is a pill that looks like the POM-X pill but does not have an active ingredient.

Subjects will receive POM-X or placebo pills daily for up to 4 weeks prior to undergoing radical prostatectomy for prostate cancer. Biomarkers in the blood, urine, and prostate tissue will be assessed.

Eligibility

Ages Eligible for Study:

18 Years and older

Genders Eligible for Study:

Male

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

Histologically confirmed adenocarcinoma of the prostate, without evidence of spread beyond to lymph nodes, bone, or visceral organs.

Radical prostatectomy scheduled at Duke or Johns Hopkins.

Initial prostate biopsy available for review with tumor involving 2 or more core biopsies based on pathologic review.

Age ≥ 18 years of age.

Willingness and ability to sign an informed consent document.

Agreement with complete abstinence from other commercially available pomegranate products during the course of the study.

No prior allergy to pomegranate dietary agents.

No significant medical or psychiatric condition that would make the patient a poor protocol candidate.

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00719030

Locations

United States, California

UCLA

Los Angeles, California, United States, 90095

United States, Maryland

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Baltimore, Maryland, United States, 21231

United States, North Carolina

Duke University Medical Center

Durham, North Carolina, United States, 27710

Sponsors and Collaborators

University of California, Los Angeles

Investigators

Principal Investigator:

Allan J Pantuck, MD

University of California, Los Angeles

Principal Investigator:

Michael Carducci, MD

Johns Hopkins Medical Center

Principal Investigator:

Stephen J Freedland, MD

Duke University

More Information

No publications provided

Responsible Party:

Allan Pantuck, Professor of Urology, University of California, Los Angeles